GLP
EMEA Guidance for laboratories that perform analysis or evaluation of clinical trial samples (so called “GCLP”)
GMP
EudraLex – Volume 4: Good manufacturing practice (GMP) Guidelines – Chapter 4: Documentation
ICH Quality Guideline Q7: GMP Guidance for Active Pharmaceutical Ingredients
(refer to section 6)
GCP
EU Directive 2005/28 (Good Clinical Practice)
Trial Master File Reference Model
Data Integrity
MHRA Guidance on GxP Data Integrity
Electronic records
FDA part 11 guidance for electronic records
International Research on Permanent Authentic Records in Electronic Systems
Model Requirements Specification for the Management of Electronic Records
Other associations
Information and Records Management Society (IRMS)
Information and Records Management Frameworks and Standards (compiled by IRMS)
The Research Quality Association